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A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00388986
First Posted: October 17, 2006
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
October 16, 2006
October 17, 2006
November 2, 2016
October 2006
July 2007   (Final data collection date for primary outcome measure)
  • AUC0-6h of plasma glucose [ Time Frame: Days -1, 6 and 12 ]
  • AUC0-12h of GK Activator (2) and metabolite. [ Time Frame: Days 6 and 12 ]
  • AUC0-tau of glyburide [ Time Frame: Days -1 and 6 ]
Pd: AUC0-6h of plasma glucose from pre-dose to 6h post-dose. Pk: AUC0-12h of GK Activator (2) and metabolite on days 6 & 12, AUC0-tau of glyburide on days -1 and 6.
Complete list of historical versions of study NCT00388986 on ClinicalTrials.gov Archive Site
AEs, laboratory parameters. [ Time Frame: Throughout study ]
Pd: Cmin, tmin, Cmax, tmax, plasma glucose. Pk: AUC0-6h, CL/F, Cmax, tmax, t1/2 of GK Activator (2) and metabolite on days 6 & 12, & of glyburide on days -1 and 6
Not Provided
Not Provided
 
A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
An Open-label, Crossover Study to Investigate the Potential Pharmacodynamic and Potential Pharmacokinetic Interaction Between Glyburide and GK Activator(2) in Type 2 Diabetes Patients Inadequately Controlled With Glyburide as Standard Prescribed Therapy.
This study will assess the potential pharmacodynamic and potential pharmacokinetic interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not adequately controlled with glyburide as standard prescribed therapy. Patients will enter the study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and glyburide treatment re-started. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Drug: GK Activator (2)
    100mg po bid
  • Drug: Glyburide
    10-20mg po daily
  • Experimental: 1
    Interventions:
    • Drug: GK Activator (2)
    • Drug: Glyburide
  • Experimental: 2
    Intervention: Drug: GK Activator (2)
  • Experimental: 3
    Intervention: Drug: Glyburide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2007
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, aged 18-75 years;
  • type 2 diabetes mellitus; currently on glyburide 10-20 mg/day for >=3 months;
  • untreated, or taken off anti-diabetic or statin therapy >=2 weeks before study start.

Exclusion Criteria:

  • type 1 diabetes mellitus, or latent autoimmune diabetes in adults;
  • diabetic neuropathy, retinopathy or nephropathy;
  • patients treated with insulin or PPAR gamma agonist with 6 weeks of screening.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00388986
NP20194
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP